Effectiveness and Cost-effectiveness of Transmural Collaborative care with Consultation Letter (TCCCL) and Duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: A randomized placebo-controlled Multi-Centre trial. TCC:PAINDIP.
- Conditions
- depressionmelancholy10027946
- Registration Number
- NL-OMON39433
- Lead Sponsor
- GGZ Breburg Groep (Rijen)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 219
Patient type: Patients, male/female. Age range: 18 years or older. Patients that present themselves with major depressive disorder with concomitant pain symptoms of more than 6 weeks duration will be included.
Patients with pain for which by diagnostic medical assessment a structural and continuing physical cause has been found in terms of tissue damage, illness or otherwise, that requires treatment, such as pain due to cancer or recent post traumatic pain, are excluded from the study and advised to seek such treatment. Other exclusion criteria are:
*a PHQ-9 < 10 or a BPI score < 3,
*alcohol use >3 units a day or drug abuse or dependence in the last 6 months, defined as current use of any hard drugs or cannabis
*psychotic symptoms or use of antipsychotic medication that may influence perception of pain;
*use of St John*s wort (Hypericum Perforatum),
*pregnancy and breastfeeding,
*inability to participate in case of too severe language barrier,
*dementia
*severe renal and liver dysfunction.
* uncontrolled hypertension
*Lastly, suicidal ideation is an exclusion criterion if this constitutes immediate danger and the need for crisis management according to the consulted psychiatrist. This will be measured with the suicidal ideation item of the PHQ-9. For this purpose, a suicide protocol is used in the study, defining degrees of suicide risk and prescribing necessary steps to be taken to advert such risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters will be effectiveness on severity of depression<br /><br>(measured by the PHQ9. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters will be to establish cost effectiveness in terms of<br /><br>QALY as measured by EuroQol-5 and SF-36 and costs measured by TIC-P; and to<br /><br>establish improvement on pain in terms of BPI.</p><br>